GB/T 22275.1-2008Requirements of conduct for Good Laboratory Practice (GLP) -- Part 1: Quality assurance and GLP (English PDF)
良好实验室规范实施要求 第1部分:质量保证与良好实验室规范
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Issued by
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China
Level / Type
National · Recommended
Issue date
August 4, 2008
Implementation date
April 1, 2009
Scope
GB/T 22275.1-2008 is the English-translated version of 良好实验室规范实施要求 第1部分:质量保证与良好实验室规范.
GB/T 22275.1-2008 — This standard specifies the principles of GLP quality assurance activities of the specific content and requirements, including quality assurance personnel responsibilities, quality assurance personnel and managers contact, personnel qualifications and quality assurance in the standard operating procedures and research program development process conditions quality assurance inspection, quality assurance activities planned and quality assurance activities and method of argument, quality assurance, inspection reports, data, and the final report of the audit, quality assurance statement, quality assurance and non-regulatory research and small-scale test of the quality assurance agencies.
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Document preview — GB/T 22275.1-2008
National Standard of the People's Republic of China
- ICS
- 03.120.20
- Classification
- A 00
Issued by: General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China
Contents
- What this standard covers1
- Document data2
- Standards quoted by this document3
What this standard covers
This standard specifies the principles of GLP quality assurance activities of the specific content and requirements, including quality assurance personnel responsibilities, quality assurance personnel and managers contact, personnel qualifications and quality assurance in the standard operating procedures and research program development process conditions quality assurance inspection, quality assurance activities planned and quality assurance activities and method of argument, quality assurance, inspection reports, data, and the final report of the audit, quality assurance statement, quality assurance and non-regulatory research and small-scale test of the quality assurance agencies. This section applies to the principles of GLP quality assurance activities.
Document data
International classification (ICS): 03.120.20.
Chinese classification (CCS): A00.
Estimated length of the Chinese original: 8,816 words.
Adopted international standard: OECD GLP, IDT; ENVJMMONO (99)20, IDT.
Standards quoted by this document
GB/T 22274.1; GB/T 22278-2008
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 6 pages — is available in the English PDF.
Referenced standards
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Related Standards
GB/T 22275.2-2008 — Requirements of conduct for Good Laboratory Practice (GLP) -- Part 2: The role and responsibilities of the study director in GLP studies
GB/T 22275.3-2008 — Requirements of conduct for Good Laboratory Practice (GLP) -- Part 3: Compliance of laboratory suppliers with GLP principles
GB/T 22275.4-2008 — Requirements of conduct for Good Laboratory Practice (GLP) -- Part 4: The application of the GLP principles to field studies
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GB/T 22275.1-2008
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